Patient-centered Development of the Cancer Support Community's Open to Options ®Chatbot Program

Sponsor
University of Michigan Rogel Cancer Center (Other)
Overall Status
Terminated
CT.gov ID
NCT04616651
Collaborator
Cancer Support Community (Other)
18
1
2
4.5
4

Study Details

Study Description

Brief Summary

This study is designed to study the feasibility and acceptability of the Open to Options (O2O) Chatbot prototype. The O2O program is an existing patient support program with content currently delivered via in-person counseling with a trained mental health professional or via an existing web-based program (Let's Talk Treatment Options).The Chatbot is an automated, menu-based agent being developed in this study to extend the reach and accessibility of the O2O program via the Chatbot's "virtual coaching".

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Online Survey
  • Behavioral: Chatbot prototype
  • Behavioral: Open to Options (O2O) Program
N/A

Detailed Description

This is a pilot study to assess feasibility and acceptability, and to gather preliminary data on how patients with a diagnosis of cancer appraise being prepared for their upcoming visit with a cancer specialist. Participants will be randomized to take a survey either before or after their Chatbot interaction. The surveys collect participants' self-appraisal regarding preparedness for their upcoming appointment with a cancer physician, cancer distress and cancer anxiety. The study will examine whether patients who take the survey after viewing the Chatbot feel more prepared for their upcoming appointment than those who take the survey before the Chatbot interaction.

Study Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Patient-centered Development of the Cancer Support Community's Open to Options ®Chatbot Program Cancer Treatment Support in Partnership With the Cancer Support Community
Actual Study Start Date :
Mar 25, 2021
Actual Primary Completion Date :
Aug 10, 2021
Actual Study Completion Date :
Aug 10, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Pre-Chatbot survey arm

Participants will take the self-appraisal survey prior to interacting with the O2O program via the online Chatbot.

Behavioral: Online Survey
Participants respond to online survey questions either before or after using the Chatbot O2O intervention.
Other Names:
  • Qualtrix Survey
  • Behavioral: Chatbot prototype
    An online, automated, menu-based agent in which all responses are pre-programmed to be consistent with the existing O2O program. The chat-like responses help guide the participant through a process with the goal of developing a list of questions for their upcoming appointment with a cancer clinician. The session is meant to be completed in one sitting and estimated to take about 45 minutes to complete (including the pre- or post-intervention survey); however, if a participant stops in the middle, they may go back and complete the Chatbot session (or survey).

    Behavioral: Open to Options (O2O) Program
    Evidence-based program developed by Cancer Support Community that helps patients actively engage in their treatment decision process by preparing them for their upcoming appointments.

    Experimental: Post-Chatbot survey arm

    Participants will take the self-appraisal survey after interacting with the O2O program via the online Chatbot. (This arm will also answer additional questions regarding participants' satisfaction with the O2O Chatbot.)

    Behavioral: Online Survey
    Participants respond to online survey questions either before or after using the Chatbot O2O intervention.
    Other Names:
  • Qualtrix Survey
  • Behavioral: Chatbot prototype
    An online, automated, menu-based agent in which all responses are pre-programmed to be consistent with the existing O2O program. The chat-like responses help guide the participant through a process with the goal of developing a list of questions for their upcoming appointment with a cancer clinician. The session is meant to be completed in one sitting and estimated to take about 45 minutes to complete (including the pre- or post-intervention survey); however, if a participant stops in the middle, they may go back and complete the Chatbot session (or survey).

    Behavioral: Open to Options (O2O) Program
    Evidence-based program developed by Cancer Support Community that helps patients actively engage in their treatment decision process by preparing them for their upcoming appointments.

    Outcome Measures

    Primary Outcome Measures

    1. Feasibility of Integrating Chatbot in Clinic [At the time of scheduling an appointment with cancer physician; one day]

      The feasibility of integrating an Open to Options (O2O) Chatbot into the clinical workflow, assessed by the number of patients who accept the invitation to receive more information about the study, among all those invited.

    2. Acceptability - Reach [Baseline (Before appointment with cancer physician); up to approximately 3 weeks after scheduling appointment]

      Assessed by the number of patients who log-in to the O2O Chatbot program and create an account, among all those who accepted the invitation to receive information.

    3. Acceptability - Uptake [Baseline (Before appointment with cancer physician); up to approximately 3 weeks after scheduling appointment]

      Assessed by the number of patients who proceed to view the full Chatbot prototype and generate a summary, among all those who created an account.

    4. Acceptability - Mean Satisfaction Scores [Baseline (Before appointment with cancer physician); up to approximately 3 weeks after scheduling appointment]

      Post-Intervention Survey Group only: In addition to the survey given to all participants, the post-intervention survey group will answer 6 questions about their perception of the Chatbot prototype. Each of the 6 questions will be scored on a scale from 1 (strongly disagree) to 5 (strongly agree). Investigators will calculate the mean value (and Standard Deviation) on a 1-5 scale for each question.

    5. Acceptability - Percent of Participants with High Satisfaction Scores [Baseline (Before appointment with cancer physician); up to approximately 3 weeks after scheduling appointment]

      Post-Intervention Survey Group only: In addition to the survey given to all participants, the post-intervention survey group will answer 6 questions about their perception of the Chatbot prototype. Each of the 6 questions will be scored on a scale from 1 (strongly disagree) to 5 (strongly agree). For each of the six questions, investigators will calculate the percentage of participants who strongly agree.

    Other Outcome Measures

    1. Mean Patient-reported Appraisal Outcomes [Baseline (Before appointment with cancer physician); up to approximately 3 weeks after scheduling appointment]

      Mean values of the following 5 self-appraisals: Cancer related distress [scale from 0 (none) to 10 (extreme)] Cancer diagnosis anxiety [scale from 0 (none) to 10 (extreme)] Self-efficacy for question asking [scale from 0 (not at all confident) to 10 (extremely confident)] Decision preparedness [scale from 1 (not at all) to 5 (a great deal)] Decision self-efficacy [scale from 0 (not at all confident) to 4 (very confident)] The mean values will be compared by group (pre- vs. post-intervention survey group) using t-tests.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with a cancer diagnosis

    • Able to speak and read English, and willing to electronically consent

    • Appointment with a Rogel Cancer Center cancer clinician within the next 3 weeks

    • Patient must have a way to access the internet (includes mobile phone)

    Exclusion Criteria:
    • Age <18 years

    • Inability to speak or read English

    • Inability to give informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Michigan Rogel Cancer Center Ann Arbor Michigan United States 48109

    Sponsors and Collaborators

    • University of Michigan Rogel Cancer Center
    • Cancer Support Community

    Investigators

    • Principal Investigator: Sarah Hawley, PhD, MPH, University of Michigan Rogel Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Michigan Rogel Cancer Center
    ClinicalTrials.gov Identifier:
    NCT04616651
    Other Study ID Numbers:
    • UMCC 2020.083
    • HUM00179538
    First Posted:
    Nov 5, 2020
    Last Update Posted:
    Aug 11, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Michigan Rogel Cancer Center

    Study Results

    No Results Posted as of Aug 11, 2022